News and updates on potential cures for type-1 diabetes, that are in human (or clinical) trials.

Sunday, August 16, 2009

Brod Completes Phase-II trial of Alpha Interferon

Brod has finished a Phase-II clinical trial of oral interferon alpha, as a possible honeymoon cure of type-1 diabetes, and has published the results. The study involved 128 people, some of whom got 5k units of interferon, others got 30k, and others got none at all; daily doses for one year. After a year, natural insulin production in response to a meal was measured. The experiment was random assignment and double blind.

The results were this: The untreated group lost 56% of their insulin production one year after diagnosis. The group treated with 30k lost 46% but the group treated with 5k lost only 29%. So the best-to-worst summary is that the treated group lost about half as much insulin production as the untreated group. This result is very similar to Diamyd's and ToleRx's Phase-II results.

The press release describes Brod's theory this way:

Brod's theory is that autoimmune diseases, which occur when the body is attacked by its own immune system, are actually an alpha interferon immunodeficiency syndrome. Interferons are a group of proteins produced by cells in response to an attack by a virus.

My translation of this, is that he thinks that type-1 (and other autoimmune diseases) are caused by a lack of alpha interferon. Therefore, dosing with alpha interferon is an obvious path to a cure.

This clinical trial was funded by Diabetes Action Research and Education Foundation, the US Gov and the Children's Hospital of Minnesota Foundation.

Abstract of the results is here:http://www.ncbi.nlm.nih.gov/pubmed/19564474?dopt=Abstract

Clinical Trial Record is here:http://www.clinicaltrials.gov/ct2/show/NCT00024518(By the way: this is one of the worst clinical trial records I've seen. Especially since the US Gov is a major contributor to this work. There is no end date, Brod is not listed as primary investigator, no description of how many patients got which treatment, etc.)There is also another clinical trial record here, but I'm not sure if this is the same clinical trial, a related one, or a totally different one:http://www.clinicaltrials.gov/ct2/show/NCT00005665

1 comment:

I am actually in the tolerx phase III trial of otelixizumab and it is working quite well for me. I have stopped using Novolog and just use Lantus. I have cut my total units that I take a day in about half, I am currently about one month after the drug (or possibly placebo) dosing. Actually, I am really using less than half because before I was dosed I was really careful of my carbohydrate consumption but now I eat much more than I was previously and my blood glucose numbers are still vastly improved. Well, another couple years in the study, hopefully this will continue to work. Wish me and all the others luck. Maybe we will have a cure or at least a good treatment soon for others with type I.

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This blog discusses cures and preventatives for type-1 diabetes that are either in human trials or just about to start. Treatments for diabetes are not generally discussed here, unless they can turn into a cure or a preventative. My definition of a cure is this:1. Blood sugar control without testing and with doctor's visits 4 times a year, or less. Any cure must result in an average lifespan close to normal.2. Does not require a lifetime of immunsuppressive drugs, so it is not trading one treatment for another. (but a couple of operations, or a short course of drugs is OK)Obviously, this is my personal definition of a cure; yours may differ.Because a cure for type-1 diabetes is likely to involve a combination of several different drugs or treatments, I try to follow research into anything which may be an important part of the cure.

My Non-Conflict of Interest Statement

For the first 10 years of running this blog, I did not work for a company doing medical research. In 2018, I started working for Bigfoot Biomedical, which is developing an "automated insulin dosing/delivery solution" (what many call an Artificial Pancreas).

I blog on research aimed at curing type-1 diabetes, and I view Bigfoot Biomedical's work as treating type-1 diabetes (not a cure at all). Therefore, I don't view this work as conflicting with my blogging. However, if you consider the kind of automated insulin dosing/delivery solution that Bigfoot is developing to be an actual cure for type-1, then this would conflict with my blogging. I think they are quite different.

I don't get paid in any way by any company working on a cure for type-1 diabetes; I never have. And that includes free samples, free travel, or free anything. I do sometimes participate in market research studies or focus groups, and they sometimes pay.

None of the hours that I have put into my blog, or the posts that I make to any web site, has ever been paid for. (Except for some very nice and heart felt thank-you emails, and those are worth more than money.)

My daughter has type-1 diabetes and participates in clinical trials. I sometimes report on trials that she participates in, but I do not reveal her participation because I consider her medical history to be private.

I sometimes "beta test" new software or devices involved in type-1 diabetes. When I'm blogging about something where I have been given special access, I say so.

In the past I have volunteered with JDRF and The NIIB Project. I currently am a fellow with JDCA. The JDRF and NIIB work was completely unpaid. JDCA has given me equipment that I use to help my blogging, and on one occasion paid for specific consulting work.